(171 days)
No
The document describes a system of dental abutments and copings, focusing on materials, dimensions, and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is a dental implant abutment system intended to support dental prostheses, not for treating a disease or condition.
No
The document describes a Multi-Unit DAS System which includes abutments and metal copings intended for use as supports for dental prostheses in patients with dental implants. This describes a therapeutic device used for restoring dental function, not a diagnostic device used for identifying a condition or disease.
No
The device description clearly details physical components made of titanium alloy and zirconia, which are hardware. The performance studies also focus on mechanical testing and material properties, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting dental prostheses in the maxillary or mandibular arch of a patient. This is a direct clinical application within the body.
- Device Description: The description details the physical components (abutments, Ti-Bases, zirconia superstructures) and their function in connecting to dental implants and supporting restorations. This is consistent with a medical device used for structural support in the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is implanted and functions mechanically.
Therefore, this device falls under the category of a medical device used for dental restoration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech OsseoSpeed TX | 3.5 | 3.5/4.0 |
| Astra Tech OsseoSpeed TX | 4.0 | 3.5/4.0 |
| Biomet 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| Biomet 3i OSSEOTITE® Certain® | 4.0 | 4.1 |
| MegaGen AnyRidge | 3.5, 4.0, 4.4, 4.9, 5.4 | 3.5 |
| NobelActive® | 3.5 | 3.5 (NP) |
| NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure.
The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm.
The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.
All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3.
All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Multi-Unit DAS System are:
Minimum wall thickness - 0.25 mm
Minimum post height for single-unit restorations - 4.0 mm
Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants
Minimum gingival height - 0.5 mm (in the Ti-Base)
Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants
The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- . provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- provided in this submission was reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement;
- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants;
- referenced from K221966 (provided in K212108) was biocompatibility testing according to ISO 10993-5 ● (cytotoxicity) covering the finished subject devices manufactured from titanium alloy (ASTM F136) with cemented zirconia superstructures (ISO 13356); and
- . non-clinical analysis also was performed to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Allovs Used in Medical Devices, " Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (issued May 2021) including magnetically induced displacement force and torque.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K230143, K220200, K101732, K063341, K140091, K110955, K142260, K013227, K072589
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
November 17, 2023
Talladium España, SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real. Suite 400 San Diego, California 92130
Re: K231559
Trade/Device Name: Multi-Unit DAS System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: October 20, 2023 Received: October 20, 2023
Dear Kevin Thomas:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231559 Device Name
Multi-Unit DAS System
Indications for Use (Describe)
Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech OsseoSpeed TX | 3.5 | 3.5/4.0 |
| Astra Tech OsseoSpeed TX | 4.0 | 3.5/4.0 |
| Biomet 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| Biomet 3i OSSEOTITE® Certain® | 4.0 | 4.1 |
| MegaGen AnyRidge | 3.5, 4.0, 4.4, 4.9, 5.4 | 3.5 |
| NobelActive® | 3.5 | 3.5 (NP) |
| NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary K231559 Talladium España, SL Multi-Unit DAS System
November 16, 2023
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Talladium España, SL
Virginia Woolf, 17
Lleida, Lleida, ES 25005
Telephone +34 973-289-580 | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Official Contact | Xavier Soca Filella, General Manager | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email kthomas@paxmed.com
flarson@paxmed.com | |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Multi-Unit DAS System |
|---|---|
| Common Names | Endosseous dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 |
| (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | |
| Reviewing Division | Division of Dental and ENT Devices |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K221966, Dynamic TiBase, Talladium España, SL
Reference Devices K230143, DESS® Dental Smart Solutions, Terrats Medical SL K220200, Paltop Conical Implant System, Paltop Advanced Dental Solutions, Ltd K101732, Astra Tech Implant System, Astra Tech AB K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc. K140091, Xpeed AnyRidge Internal Implant System, MegaGen Implant Company, Ltd. K110955, AnyRidge Internal Implant System, MegaGen Implant Company, Ltd.
5
K142260, NobelActive®, Nobel Biocare AB K013227, Screw Vent Implant; Tapered Screw Vent Implant, Sulzer Dental, Inc. K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.
INDICATIONS FOR USE STATEMENT
Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| Astra Tech OsseoSpeed TX | 3.5 | 3.5/4.0 |
| Astra Tech OsseoSpeed TX | 4.0 | 3.5/4.0 |
| Biomet 3i OSSEOTITE® Certain® | 3.25 | 3.4 |
| Biomet 3i OSSEOTITE® Certain® | 4.0 | 4.1 |
| MegaGen AnyRidge | 3.5, 4.0, 4.4, 4.9, 5.4 | 3.5 |
| NobelActive® | 3.5 | 3.5 (NP) |
| NobelActive® | 4.3, 5.0 | 3.9 (RP) |
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
Compatible Implant Systems
All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
Multi-Unit DAS System abutments are designed for retention of single-unit and multi-unit restorations. The multi-unit abutments are provided in a straight design (no angulation in the base portion) that threads directly to the OEM implant. For each of the compatible OEM implant lines, the multi-unit abutments are provided with gingival heights ranging from 1 mm to 5 mm, a prosthetic platform diameter of 4 mm, and a prosthetic post height of 1.4 mm. The multi-unit abutments are the base of a two-piece abutment. The second piece is a metal coping, called a Ti-Base in this submission, that attaches to the multi-unit abutment (not directly to an implant). For permanent restorations a zirconia superstructure is attached to the Ti-Base, and additional gingival height and angulation may be provided in the zirconia superstructure.
The subject device metal copings (Ti-Bases) include: a straight, prepable design with an additional gingival height of 1.5 mm and a prepable 9 mm prosthetic post; and Dynamic Ti-Bases in three (3) designs, each with an additional gingival height of 0.5 mm and a cut-out in the prosthetic post to accommodate a restoration with an angled screw channel when clinically necessary. The Dynamic Ti-Base prosthetic post heights are 4.5 mm (maximum height) / 3.0 mm (cut-out height), and 9.0 mm/3.5 mm. Multi-Unit DAS System Ti-Bases with a 9.0 mm post height may be shortened to no less than 4 mm for a single-unit restoration. The prepable Ti-Base has a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4 mm. The Dynamic Ti-Bases have a platform diameter of 4 mm (platform to the multi-unit abutment) and a prosthetic platform diameter of 4.15 mm.
The compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement was established by reverse engineering analysis of the OEM implants, OEM abutments, and OEM abutment screws.
All subject device abutments and abutment screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5832-3.
6
510(k) Summary Page 3 of 8
All zirconia copings (superstructures) for use with the subject device Dynamic Ti-Base will be made at a Talladium España, SL validated milling center under FDA quality system regulations, and the material will conform to ISO 13356.
The design parameters for the CAD-CAM zirconia superstructure for the Multi-Unit DAS System are:
Minimum wall thickness - 0.25 mm
Minimum post height for single-unit restorations - 4.0 mm
Maximum gingival height in the zirconia superstructure - 5.24 mm for compatible Biomet 31 OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 5.76 mm for compatible Astra Tech OsseoSpeed TX implants
Minimum gingival height - 0.5 mm (in the Ti-Base)
Maximum angulation - 30° for compatible Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, NobelActive®, and Zimmer Tapered Screw-Vent® implants; 25° for compatible Astra Tech OsseoSpeed TX implants
The recommended cement for bonding the zirconia superstructure to the Dynamic TiBases to create the final two-piece abutment is G-CEM LinkAce™, cleared as GAM-200 in K120243.
PERFORMANCE DATA
Non-clinical data submitted or referenced to demonstrate substantial equivalence included:
- . provided in this submission was moist heat sterilization for subject devices provided non-sterile to the end user, validated to a sterility assurance level of 105 by the overkill method according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2;
- provided in this submission was reverse engineering analysis (of OEM implants, OEM abutments, and OEM abutment screws) demonstrating compatibility between the subject device abutments and the OEM implants listed in the Indication for Use Statement;
- . provided in this submission was mechanical testing conducted according to ISO 14801 to support the performance of the subject device abutments in conjunction with the compatible OEM implants;
- referenced from K221966 (provided in K212108) was biocompatibility testing according to ISO 10993-5 ● (cytotoxicity) covering the finished subject devices manufactured from titanium alloy (ASTM F136) with cemented zirconia superstructures (ISO 13356); and
- . non-clinical analysis also was performed to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Allovs Used in Medical Devices, " Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (issued May 2021) including magnetically induced displacement force and torque.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device K221966, and the reference device K230143.
7
The primary predicate device K221966 is for support of substantial equivalence in terms of abutment designs, materials, manufacturing, biocompatibility, and sterilization. The reference device K230143 is for support of substantial equivalence in terms of abutment designs. The reference devices K101732, K063341, K140091, K110955, K142260, K013227, and K072589 are for the OEM implant sizes.
The subject device abutments are substantially equivalent in intended use to the abutments cleared in primary predicate device K221966 and the reference device K230143. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation. The Indications for Use Statement (IFUS) for the subject device is identical to that of the primary predicate device K221966 except for the marketing names and the list of compatible OEM implants. The IFUS for the subject device also is similar to that of the reference device K230143 except for the marketing names and the list of compatible OEM implants.
All subject device multi-unit abutments are similar in design, materials, and technological characteristics to the multi-unit abutments cleared in the primary predicate device K221966 and the reference device K230143. The subject device and the reference device K220200 include multi-part abutments (finished device comprising a non-engaging multi-unit abutment, a metal coping, and a zircoma superstructure) for single-unit restorations.
The subject device abutments and prosthetic components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Talladium España, SL abutments and abutment screws previously cleared in the primary predicate device K221966.
The subject device multi-unit abutments and the multi-unit abutments in the reference device K230143 have similar or identical ranges of implant-abutment platform diameter, prosthetic platform diameter, and gingival height.
The subject device Ti-Base components are to be used with a zirconia superstructure with similar design parameters as the primary predicate K221966. The zirconia material and recommended cement to bond the superstructure to the prosthetic component is the same as the primary predicate K221966.
All abutment screws are similar in design, materials, and technological characteristics to those cleared in the primary predicate device K221966, except for the threads and lengths.
Subject device components that are provided non-sterilized by the same moist heat cycle as in the primary predicate K221966. The subject devices are provided in pouches manufactured from a polyethylene terephthalate (PET) and cast polypropylene (CPP) laminate, identical to the primary predicate K221966.
The subject device Multi-Unit Abutments are to be used with the subject device Ti-Bases to create the final two-piece abutment. The risks associated with the use of an angled zirconia superstructure bonded to the subject device Ti-Bases attached to the subject device Multi-Unit Abutments were mitigated by mechanical testing performed according to ISO 14801.
Minor differences in the designs, dimensions, sizes, or compatible implant lines among the subject device, the primary predicate device K221966, and the reference device K230143 do not affect substantial equivalence. These minor differences do not impact safety or effectiveness because these differences are related to the compatible implant designs and are mitigated by the mechanical performance testing.
8
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device and the primary predicate device encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.
9
Substantial Equivalence – Indications for Use Statement
| Indications for Use Statement | ||
|---|---|---|
| Subject Device | ||
| K231559 | ||
| Multi-Unit DAS System | ||
| Talladium España, SL | Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or | |
| Compatible Implant Systems | ||
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
| Astra Tech OsseoSpeed TX | 3.5 | |
| 4.0 | 3.5/4.0 | |
| 3.5/4.0 | ||
| Biomet 3i OSSEOTITE® Certain® | 3.25 | |
| 4.0 | 3.4 | |
| 4.1 | ||
| MegaGen AnyRidge | 3.5, 4.0, 4.4, 4.9, 5.4 | 3.5 |
| NobelActive® | 3.5 | |
| 4.3, 5.0 | 3.5 (NP) | |
| 3.9 (RP) | ||
| Zimmer Tapered Screw-Vent® | 3.7, 4.1 | 3.5 |
| All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture. | ||
| Primary Predicate Device | ||
| K221966 | ||
| Dynamic TiBase | ||
| Talladium España, SL | Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edem | |
| Implant Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
| Kontact™ Dental Implant System | 3.6 | |
| 4.2 | ||
| 4.8 | ||
| 5.4 | 3.6 | |
| 4.2 | ||
| 4.8 | ||
| 5.4 | ||
| All digitally designed custom abutments for use with Dynamic TiBase abutments are to be sent to a Talladium validated milling center for manufacture. |
ully edentulous patient.
ulous patient.
10
Substantial Equivalence – Indications for Use Statement
| Indications for Use Statement | ||
|---|---|---|
| Reference Device | ||
| K231043 | ||
| Terrats Medical SL | ||
| DESS® Dental Smart Solutions | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | |
| Compatible Implant Systems | ||
| Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm |
| Internal Hex Connection | ||
| Legacy1 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| Legacy2, simplyLegacy2, | ||
| Legacy3, simplyLegacy3, | ||
| Legacy4 | 3.7 | 3.5 |
| 4.2 | 3.5 | |
| 4.7 | 4.5 | |
| 5.2 | 4.5 | |
| Internal Conical Connection | ||
| InterActive | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.3 | 3.4 | |
| 5.0 | 3.4 | |
| Simply Iconic™ | 3.2 | 3.0 |
| 3.7 | 3.0 | |
| 4.2 | 3.0 | |
| 4.7 | 3.0 | |
| 4.7 | 3.4 | |
| 5.2 | 3.4 | |
| 5.7 | 3.4 |
11
Table of Substantial Equivalence – Technological Characteristics
| Comparison | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| K231559 | |||
| Multi-Unit DAS System | |||
| Talladium España, SL | K221966 | ||
| Dynamic TiBase | |||
| Talladium España, SL | K231043 | ||
| Terrats Medical SL | |||
| DESS® Dental Smart Solutions | |||
| Reason for Predicate Device | Not applicable | Abutment designs, materials, manufacturing, biocompatibility, and | |
| sterilization | Abutment designs | ||
| Product Codes | NHA | NHA | NHA |
| Intended Use | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Functional and esthetic rehabilitation of the edentulous mandible or maxilla |
| Abutment Designs | |||
| Abutment Types | Multi-unit, straight (0°) | CAD-CAM Titanium Base Abutments | Multi-unit, straight (0°), 17°, 30° |
| Prosthesis Attachment | Screw retained | Cement-retained, screw-retained | Screw retained |
| Restoration | Multi-unit | Single-unit and multi-unit | Multi-unit |
| Prosthetic Interface Connections | Internal | Internal | Internal |
| Implant-Abutment Platform Diameter | 3.4 mm - 4.1 mm | 3.6 mm - 5.4 mm | 3.0 mm - 4.5 mm |
| Prosthetic Platform Diameter | 4.0 mm, Multi-unit Abutments | ||
| 4.15 mm Ti-Base for Multi-unit Abutments | 4.0 mm, 4.5 mm | 4.8 mm | |
| Gingival Height | 1 mm - 5 mm | 1 mm (minimum) | 1 mm - 5 mm |
| Abutment Angulation, degrees | Straight (0°) | Straight (0°) | Straight (0°), 17°, 30° |
| Zirconia Superstructure Design Parameters | |||
| Minimum wall thickness | 0.25 mm | 0.55 mm | Not applicable |
| Minimum post height for single-unit restorations | 4.0 mm | 4.0 mm | Not applicable |
| Minimum gingival height (GH) of the | |||
| superstructure | 0 mm; all Ti-Bases have minimum GH 0.5 mm | 0 mm; all bases have minimum GH of 1 mm | Not applicable |
| Maximum gingival height (of the superstructure) | 5.24 mm for Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, | ||
| NobelActive®, and Zimmer Tapered Screw-Vent® implants | |||
| 5.76 for Astra Tech OsseoSpeed TX implants | 5.37 mm | Not applicable | |
| Angulation of Finished Abutment | Up to 30° for Biomet 3i OSSEOTITE® Certain®, MegaGen AnyRidge, | ||
| NobelActive®, and Zimmer Tapered Screw-Vent® implants | |||
| Up to 25° for Astra Tech OsseoSpeed TX implants | Up to 30° | Not applicable | |
| Cement to bond zirconia superstructure to the | |||
| abutment base | G-CEM LinkAce™ (cleared as GAM-200 in K120243) | G-CEM LinkAce™ (cleared as GAM-200 in K120243) | Not applicable |
| Abutment Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Ti-6Al-4V ELI |
| Abutment Screw Material | Titanium alloy, ASTM F136 | Titanium alloy, ASTM F136 | Ti-6Al-4V ELI |
| Superstructure Material | Zirconia, ISO 13356 | Zirconia, ISO 13356 | Not applicable |
| How Provided | |||
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Usage - All Components | Single patient, single use | Single patient, single use | Single patient, single use |